Details for New Drug Application (NDA): 207960
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NDA 207960 describes QUILLICHEW ER, which is a drug marketed by Nextwave Pharms and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the QUILLICHEW ER profile page.
The generic ingredient in QUILLICHEW ER is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in QUILLICHEW ER is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 207960
| Tradename: | QUILLICHEW ER |
| Applicant: | Nextwave Pharms |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 10 |
Pharmacology for NDA: 207960
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 207960
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUILLICHEW ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 207960 | NDA | NextWave Pharmaceuticals, Inc | 24478-074 | 24478-074-01 | 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-01) |
| QUILLICHEW ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 207960 | NDA | NextWave Pharmaceuticals, Inc | 24478-075 | 24478-075-01 | 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-075-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 4, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 14, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 14, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 14, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED | ||||||||
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